Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00021424|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Metastatic Cancer||Biological: recombinant fowlpox-TRICOM vaccine||Phase 1|
- Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases.
- Determine the safety profile of this regimen in these patients.
- Determine the clinical activity of this regimen, in terms of inflammation at injection site(s) and disease regression or stabilization, in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant fowlpox-TRICOM vaccine (rF-TRI) intralesionally once on weeks 0, 3, and 8. Beginning on week 16, patients may receive additional rF-TRI once every 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of rF-TRI until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I/Pilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck|
|Study Start Date :||June 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021424
|United States, Maryland|
|Warren Grant Magnuson Clinical Center|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Susan Rudy, MSN||National Institute on Deafness and Other Communication Disorders (NIDCD)|